1. Field of the Invention
The present invention relates to a modular easy-to-assemble low cost sheet metal formed disposable modular spherical hollow reamer assembly for medical applications that has a bone fragment and bone debris capturing cavity, and can be attached concentric to a reusable shaft.
2. Description of the Prior Art
Reaming of the internal canal of bones is required in many surgical procedures of orthopedic surgery. These procedures include hip replacement and shoulder replacement, and the like. Reamers are used in procedures that involve creation of acetabular bone cavities that accept a properly sized acetabular cups. Prior art reamers typically fall into two major classes: rigid and flexible shaft. Typically, reaming of the internal bone cavity is achieved through utilization of a spherical reamer some having provisions for discharging and collecting reamed bone fragments. Spherical reamers currently utilized are required to cut both cancellous bone (spongy bone) and cortical bone (hard bone). Cortical bone is generally denser and stronger, requiring an efficient cutter to machine the acetabular cavity for a proper fit of the acetabular cup. Conventional spherical reamers can cut cortical bone initially but can quickly dull after a single use, or at best a few uses. Once the reamer has dull cutting edges, it reduces the efficiency of bone cutting and in addition generates sufficient friction/heat to damage or kill the surrounding bone. These prior art solid spherical reamers are intended for multiple uses and therefore become less efficient after each surgery, resulting in poor cutting performance and bone necrosis. These dull blades also incorporate bone debris or bone cement debris into the living bone tissue, creating bone healing problems and fixation of an implanted acetabular cup.
U.S. Pat. No. 4,116,200 to Braun et al. discloses a milling tool for surgical purposes. This surgical milling tool is operated with a hand-operated milling machine for milling the heads or sockets of bone joints of a spherical shape. The tool is formed of a hemispherical cup integrally formed with a cylindrical skirt and flange and is provided with a plurality of openings of semi-oval shape, each having a cutting edge arranged at the minor axis of the oval shape. The openings are situated such that, upon rotation of the cup, the cutting edges thereof overlap to provide a continuous cutting edge surface conforming generally to the shape of the cup. The formation of fine bone shavings is avoided by use of this milling tool. The surgical milling tool utilizes a integrally formed hemispherical cup having a plurality of openings appointed with cutting edges for milling sockets of bone joints. The hemispherical shape of cup provides the ability to hollow out the arcuate shape of the bone joints. Bone and cartilage shavings are formed during the milling process and are collected in a border area inside of the hemispherical cup. The surgical milling tool is provided for multiple use and is not a disposable spherical hollow reamer, and therefore the tool will become less efficient after each surgery, resulting in poor cutting performance and bone necrosis.
U.S. Pat. No. 4,811,632 to Salyer discloses surgical reamer. a method of producing an acetabular reamer cup. This method comprises the steps of fabricating a bowl-shaped cup-blank having an outer surface, an inner surface and a rim, perforating a plurality of holes through the cup-blank, the holes each being surrounded by a margin, deforming outwardly a cutting portion of the margin of each of the holes, smoothing the outer surface of the cup-blank to sharpen the deformed cutting portions, raising cutting edges from the cutting portions and removing the rim. The cutting edges are disposed to cut upon rotation of the acetabular reamer. The cup manufactured by this method is preferred because of its improved strength and consistently superior cutting edges. The acetabular reamer utilizes a hemispherical or bowl-shaped cup having a spherical construction and a plurality cutting openings for milling sockets of joints. The hemispherical shape of reamer provides the ability to hollow out the arcuate shape of the bone joints. The acetabular reamer is provided for multiple use, and therefore the tool will become less efficient after each surgery, resulting in poor cutting performance and bone necrosis.
U.S. Pat. No. 5,100,267 and its continuation in part U.S. Pat. No. 5,299,893 to Salyer disclose a disposable acetabular reamer cup. The disposable acetabular reamer cup has a cutting bowl having a plurality of cutting edges. The cutting bowl has perforations adjoining the cutting edges. The cutting bowl defines an axis of rotation. The cutting bowl has a bottom opening. A transparent polymeric plug is joined to the cutting bowl. The plug is concentric with the axis of rotation. It occupies the bottom opening; and has a tool driver opening concentric with the axis of rotation. When a torque is applied, the bowl is turned with respect to the plug, which means that the cutting torque is transmitted through the plug and transferred to the cutting plug through the detents. There is no direct connection between the shaft and the cutting bowl other than through the plug. Concentricity of the cutting bowl with respect to that of the shaft is therefore not assured.
U.S. Pat. No. 5,116,165 to Salyer discloses an acetabular reamer cup. This acetabular reamer cup comprises a cutting bowl having a plurality of singly curved cutting edges. The cutting bowl has a plurality of slots preceding the cutting edges. The cutting bowl defines an axis of rotation. A bottom is joined to the cutting bowl. The bottom has a tool driver opening concentric with the axis of rotation. With a right handed acetabular reamer cup that cuts when pressed against a substrate and rotated in a clockwise direction, slots are positioned to the right of respective cutters. There is no direct connection between the shaft and the cutting bowl other than through the base aperture. The concentricity of the cutting bowl with respect to that of the shaft is therefore not assured.
U.S. Pat. No. 5,302,234 to Grace, et al. discloses surgical cutting instrument forming method. This surgical cutting instrument is a sheet metal tool that is not planar, and the tools is made from a sheet metal blank, which has a first surface and an opposing second surface. A etching resistant material is applied to the first surface and etched by a chemical etching agent to form a sharp edge that terminates on the second surface coated with a etch resistant material. There is no indication how this non planer chemically etched tool is mounted concentrically on a shaft.
U.S. Pat. No. 5,658,290 to Lechot discloses an assembly comprising reamer spindle and reamer for surgery. The reamer comprises a cap and at least three radial rods which are arranged uniformly on the inside edge of the cap and join up integrally at the center of the cap. The reamer spindle comprises a shank on which there is fixed a reamer spindle head that is equipped with a bayonet with locking means for the securing of the reamer. The securing catches of the bayonet are intended to receive the radial rods of the reamer. The connection between the reamer rods and bayonet does not provide a precise centerline matching arrangement.
U.S. Pat. No. 5,709,688, as well as U.S. Pat. Nos. 6,001,105, and 6,428,543 to Salyer disclose an acetabular reamer cup and method of producing the same. This method for making an acetabular reamer cup for an acetabular reamer comprises the steps of: fabricating a bowl shaped cup-blank having outer and inner bowl shaped surfaces, perforating a plurality of holes through the cup-blank, the holes each are surrounded by a curved margin, deforming outwardly of the outer surface a cutting portion of the margin of each of the holes, thereby forming cutting edges, the cutting portions are curved outwardly of the outer surface, the cutting edges are curved tangentially of the outer surface and disposed to cut upon rotation of the acetabular reamer. An acetabular reamer cup is also provided with a cutting bowl having a plurality of curved cutting edges. The cutting bowl has a plurality of openings preceding the cutting edges, and a generally conical rise following the cutting edges. The cutting edges are spirally arranged about the axis of rotation of the cutting bowl, and a bottom adjoined to the cutting bowl. The bottom has a tool driver opening coaxial with the cutting bowl and the cutting edges. Bone debris collection compartment is located directly below the actabular reamer. Bottom of the acetabular reamer has a tool driver opening, which is concentric with the cutting bowl. The driver opening engages with the shaft, which drives the acetabular reamer. This form of attachment of the shaft with the acetabular reamer does not ensure alignment of axis of the shaft with that of the acetabular reamer. The acetabular reamer is not indicated to be disposable.
U.S. Pat. No. 5,755,719 to Frieze, et al. discloses an acetabular reamer. This acetabular reamer includes a base, a first set of semi-circular blades attached to the base, and a second set of semi-circular blades also contacting said base, and crossing and intersecting with said first set of blades at right angles thereto. The base preferably comprises a circular plate having a hexagonal drive hole in the center thereof and a plurality of slots in the periphery thereof for anchoring the blades. Each semi-circular blade includes a first end having a projection thereon, a second end opposite from said first end and also having a projection thereon, a first edge having serrated cutting teeth thereon, a second edge opposite from said first edge, and a first and second side surface. The cutting edge of the first set of blades includes a plurality of outwardly facing slots, which mate with and engage a second set of inwardly facing slots in the second edge of said second blades. When the first and second set of blades are assembled in this fashion the cutting edges of both sets of blades lie in the same spherical plane. The projections can comprise snap-in projections that automatically lock in position or projections that can be twisted and locked into position. Alternatively, the base can comprise a pair of upper and lower plates with apertures in the upper plate such that when the blade projections mate with the apertures, riveting of the lower plate with respect to the upper plate locks the projections and their related blades into position on the base. When the reamer is assembled it has a hemispherical shape suitable for reaming the acetabulum of the hip so that the acetabular portion of a hip implant properly fits into the acetabulum. The acetabular reamer is an open structure and the bone fragments will migrate back into the cutting zone, since no containment space is formed by the open structure of the cutter blades inserted into the base. The drive shaft is coupled to a hexagonal aperture in the base plate. This method of attachment does not align the hemispherical cutter centerline with that of the drive shaft. As such, the arrangement causes wobbliness of the cutter in the bone cavity.
U.S. Pat. No. 5,976,144 to Fishbein et al. discloses a hollow dome reamer with removable teeth. This surgical reamer has a hollow dome with apertures spaced apart arranged in arcs extending from an apex of the dome to the base portion of the dome. Removable teeth are positioned in the apertures. Each cutting tooth has a flange that is aligned flush with the external surface of the dome, and a raised cutting edge extending above the flange and the external surface of the dome. An interior passageway communicates between the outside and inside of the dome. A base plate is removably secured on the base portion of the dome to provide closure of the central cavity of the dome. A perspective view of the cutter of the reamer is shown hereinbelow on the left; a perspective view of the reamer with removable, replaceable cutters is shown herein on the right. The base plate is secured to the dome by retaining springs. A drive shaft is connected to the base plate through an aperture in the base plate and held in place by a spring. The surgical reamer has a hollow dome with apertures spaced apart appointed to receive removable teeth positioned therein. Although the teeth are removable, they are not disposable in nature; the teeth are removed for replacement or for re-sharpening and are used again. The dome is connected to a base plate, which is further connected to a shaft member and retained by a spring clip and an interlocking latch. There is no direct attachment of the shaft to the dome and this multitude of connections to the shaft does not assure that the centerline of the shaft coincides with that of the hollow dome.
U.S. Pat. No. 5,980,170 to Salyer as well as U.S. Pat. Nos. 5,817,096, 5,501,686, 5,282,804, 5,236,433, 5,171,313, 5,171,312 disclose a tool driver. This tool driver has a shaft with a longitudinal axis and opposite ends. A boss is secured at one of said shaft ends by which the tool driver is connected to a rotary tool. A tool collate is secured at the other of the shaft ends by which the tool driver may be driven by a surgical hand piece having a chuck in which the collate may be positioned. The boss has a distal end surface with a groove therein. Both the groove and the distal end surface extend transversely of the axis. A pin is positioned in the groove on the axis. A latch mechanism is provided to hold a mounting bar of a rotary tool in the groove on the pin, whereby the rotary tool is held exactly coaxially of the driver during use. The rotary tool, which is used with the driver has a bar which has the same dimensions as the groove in the boss of the tool driver of the invention. The bar thus fills the slot and is complementary to the slot. The bar has a hole therein which is complementary to the pin. The pin extends coaxially of the shaft and the boss. The bar hole in which the pin of the tool driver is positioned is precisely coaxial of the axis of the tool about which the cutting edges are precisely positioned. The tool driver has a shaft appointed to receive acetabular reamer cups and patella cutters. The cutters are appointed to be connected to the tip of the shaft by means of mounting bar in the cutter and a slot in the shaft secured by a complementary pin. This method of attachment—using a mounting bar that slides into a slot—does not align the centerline of the shaft with that of the reamer.
U.S. Pat. No. 6,168,600 to Grace, et al discloses an acetabular reamer backing plate and method of use. The backing plate for an acetabular reamer assembly that has a planar surface allows for the attachment of a reamer driver. The rigid backing plate terminates in an outer circumferential edge, the outer circumferential edge being coupled to the peripheral bottom edge of the cutting cup. The rigid plate has an internal edge profile that has at least two finger elements protruding from the outer circumferential edge towards a central vertical axis drawn perpendicular to the planar surface of the plate form a holding opening for a reamer driver. The internal edge profile of the backing plate forms an observation opening to allow visual inspection of bone fragments. This attachment feature only uses a single point attachment of the reamer to the shaft at the edge profile of the backing plate. It is therefore subject to displacement of the shaft laterally, causing the centerlines of the shaft and reamer to be not precisely aligned.
U.S. Pat. No. 6,409,732 to Salyer discloses a tool driver. This tool driver has a shaft with a longitudinal axis and opposite ends. A boss is secured at one of the shaft ends by which the tool driver is connected to a rotary tool. A tool collate is secured to the other of the shaft ends by which the tool driver may be driven by a surgical hand piece having a chuck in which the collate may be positioned. The boss is equipped with a securing device of the bayonet type having a latch mechanism, which holds the rotary tool on the boss coaxially of the driver during use. The securing device has a tapered bore extending from the distal end of the boss axially of the shaft. The rotary tool has a diametrical bar extending across a bottom tool driver opening with a centrally located circular disk therein. The disk of the rotary tool fits within the bore of the tool shaft boss so as to concentrically locate the rotary tool and the tool shaft on the same axis. The latch mechanism holds the tool driver and the tool together in this position, whereby rotary tools of a multitude of sizes can be secured concentrically to the tool shaft without holding a plurality of critical tolerances when machining the bayonet type securing device or the rotary tool bottom bar. The tool driver is a shaft with a slot on the end that receives the acetabular reamer. It deals with the details of the device for attaching the acetabular reamer to the shaft. This type of slotted attachment does not result in coaxial mounting of the reamer that is coincident with the centerline of the shaft, even though the different components of the shaft are said to be coaxially aligned. The reamer is not indicated to be disposable.
U.S. Pat. No. 6,730,094 to Salyer et al. discloses cutting edges for reamers and a method for making same. Each reamer has a plurality of cutters spirally arranged on reamer surface. Each cutter has a continuous cutting edge. Edges may be generally straight in planes perpendicular to the reamer surface or tangential or parallel to the tangential plane with respect to the reamer surface. Cutting edges may also be curved in planes perpendicular to the reamer surface or parallel or tangential to the reamer surface. Further, the curvature may be convex, or concave or of other complex shapes. There need be no relationship between the shape of cutting edges and the shape of reamer surface. In fact, one may be curved and the other straight, or both may be curved in the same or opposite directions. These relate to the edge geometry of the cutting edges of the reamer. As explicitly stated in the summary, “It is also an advantage of the invention to provide a new and improved reamer that can be stripped in the field and sterilized for re-use, and which does not have crevices and other structures to hold bone chips and tissue which cannot be easily dislodged prior to sterilization”, the reamer is intended to be reused after sterilization and is not a disposable spherical reamer.
U.S. Pat. No. 6,875,217 to Wolford discloses an orthopedic reamer assembly. This orthopedic reamer assembly includes a reamer with a generally hemispherical shell having a concave side and at least one attachment feature associated with the concave side. A driver is attachable to the reamer and has a shaft with a reamer end. A releasable collar is disposed on the reamer end, which includes a boss having at least one retaining pin. A sleeve is fitted over the boss and includes a groove that is proximate to a corresponding retaining pin. The reamer has a cavity in the reamer end with a biasing element. The biasing element biases the sleeve in a closed position respective to the boss. A release pin, which press fits into the sleeve is provided in the reamer end, and is conveyed through the cavity, with the biasing element biasing against the release pin. The orthopedic reamer assembly is a complicated attachment of design of the drive shaft to an acetabular reamer with multiple sliding parts. Since each of the sliding parts requires a sliding fit, there are inherent displacement possibilities and therefore, the centerline of the shaft is not reliably aligned with the centerline of the acetabular reamer. Moreover, the acetabular reamer is not indicated to be a disposable spherical hollow reamer and requires complicated machined elements to enable a sliding fit.
U.S. Pat. No. 6,951,563 to Wolford discloses orthopaedic reamer with flat cutting teeth. An orthopaedic reamer for cutting bone includes a shaft and a head coupled with the shaft. The head includes a distal face with a plurality of punched cutting teeth. Each cutting tooth includes a hole extending through the head. At least a portion of each hole has a substantially round perimeter. A raised lip is positioned adjacent to and extends around at least part of the substantially round portion. A reamer-to-shaft attachment that has concentricity is not disclosed.
U.S. Pat. No. 6,978,648 to Wolford discloses an acetabular reamer lipping system and method. This is a lipping tool for lipping an acetabular reamer. The lipping tool has a bending form with a curved surface and a bending form axis of rotation. A pressure tool has a pressure tool curved surface adjacent to and complimentary with the bending form curved surface. The pressure tool has a pressure tool axis. The pressure tool is rotatable about the pressure tool axis and is also rotatable about the bending form axis. This lipping tool merely bends a spherical hollow reamer into shape and does not disclose how this lipped reamer is attached concentric to a shaft that rotates the reamer.
U.S. Patent Application Publication No. 2003/0181916 to Wolford discloses an orthopedic reamer with flat cutting teeth. This orthopedic reamer is for cutting bone and includes a shaft and a head coupled with the shaft. The head includes a distal face with a plurality of cutting teeth. Each cutting tooth includes a hole extending through the head. At least a portion of each hole has a substantially round perimeter. A raised lip is positioned adjacent to and extends around at least part of the substantially round portion. The '916 publication discloses an orthopedic reamer with flat cutting teeth having a shaft attached to acetabular reamer cups. The reamer cups of the '916 publication are not disposable in nature. The orthopedic reamer with flat cutting teeth publication does not provide a spherical hollow reamer assembly including a space for capturing bone fragments or bone cement debris. The attachment of the acetabular reamer to the drive shaft includes a complicated mechanism and does not reliably align the centerline of the drive shaft with that of the acetabular reamer. As such, wobble free rotation is not provided.
U.S. Patent Application Publication No. 2006/0095041 to Fehlbaum et al. discloses a contoured reamer teeth and method for their manufacture. An acetabular reamer has a cutting shell having a series of doubly curved cutting teeth of a quantity to substantially reduce a cutting pressure on each tooth as well as to reduce a size of a typical chip generated upon cutting. Substantially all the teeth each have a matched arc cutting edge of substantial length that has a cutting profile which substantially matches a profile of a shape to be cut. The apertures in which the cutting edges are formed from a sheet material and have at least one flat edge formed by a punch. Such a configuration reduces the number of teeth required to cut the shape. The contoured reamer teeth publication does not provide a procedure for assembling a reamer. In addition, the contoured reamer teeth are not disposable in nature, and therefore over time will become dulled, thereby causing enhanced friction during reaming and potentially damaging the bone.
U.S. Patent Application Publication No. 2006/0235539 to Blunn et al. discloses a surgical kit for hemiarthroplasty hip replacement. This kit comprises a femoral head and a reamer. The kit is suited for performing a hip hemiarthroplasty, in which a femoral head is fitted directly into a socket reamed into the acetabular without any permanent liner or prosthetic acetabular being implanted. The reamer is used to ream out the acetabulum until cancellous bone is exposed so that it bleeds liquid containing stem cells. The spherical shape of reamer provides the ability to hollow out the arcuate shape of the bone joints. The surgical kit disclosed by the '539 publication is provided for multiple use, and therefore the tool will become less efficient after each surgery, resulting in poor cutting performance and bone necrosis. Significantly, the '539 publication does not teach a disposable spherical hollow surgical reamer tool that is attached to a drive shaft with coincident centerlines.
U.S. Patent Application Publication No. 2008/0243124 to Fehlbaum, et al. discloses contoured Reamer Teeth and Method of Manufacture. An acetabular reamer is designed for cutting a required cut shape. The reamer has a cutting shell having a series of doubly curved cutting teeth of a quantity to substantially reduce a cutting pressure on each tooth as well as to reduce a size of a typical chip generated upon cutting. Substantially all the teeth each have a matched arc cutting edge of substantial length that has a cutting profile which substantially matches a profile of a shape to be cut. The apertures in which the cutting edges are formed have at least one straight edge by which a punch may be used in the process of forming the oriented edge. This disclosure deals with preparing cutting edges by first forming apertures with one flat edge using a laser in a spherically formed sheet and using a punch against the flat edge to create a cutting edge. There is no disclosure in the application regarding the concentric attachment of a reamer with a shaft.
U.S. Patent Application Publication No. 2009/0088757 to Tulkis discloses an acetabular reamer. The reamer assembly includes a tool driver and a tool. Tool driver comprises a shaft. The tool receiving end of the shaft has a flange. Formed in the flange are four L-shaped bayonet catches, which receive the tool. The tool has a body having slots. A cutter can slidably fit into the slots. When installed in the slots, the cutters project slightly above the body. The projecting portions of the cutters form the cutting edges for shaving or cutting tissue. The reamer is formed by attaching a tool to the tool driver by lowering it in the L-shaped bayonet catches. The reamer can be coupled to a drive means such as a hand drill and inserted in a body cavity. Operating the reamer against body tissue shaves of body tissue. This type of four L-shaped bayonet catches attaching a shaft to a reamer does not provide precise alignment of the centerline of the reamer and shaft since it is a single location attachment.
U.S. Patent Application Publication No. 2009/0163921 to Lechot et al. discloses disposable acetabular reamer from flat stock. This disposable reamer has a reamer assembly that includes a rigid, circular molded biocompatible plastic base with an interface for mating with a holder and a press-formed, thin walled, perforated and toothed cutting body having interlocking interfaces for locking with the base. The base has an aperture 19 for attachment to a shaft. This form of attachment is a single point attachment to a deformable plastic body and will not maintain a precise alignment of the centerline of the shaft and that of the reamer especially after use when the polymer base aperture deforms.
Foreign Publication No. WO 9007908 to Schelhas discloses an acetabulum reamer. Acetabulum reamer for reaming the acetabulum of the human pelvic bone prior to insertion of an artificial hip joint cup comprises a reamer head on a shaft and a spiral reaming ridge arranged about the axis of the shaft and provided with reaming devices. The outer edge of the reaming ridge is delimited by a section of a spherical surface whose axis of rotation is flush with the axis of the shaft. The acetabulum reamer utilizes a spherical head for reaming a socket in an acetabulum. The spherical shape of reamer provides the ability to hollow out the arcuate shape of the bone joints. The reamer is provided for multiple use, and therefore the tool will become less efficient after each surgery, resulting in poor cutting performance and bone necrosis. Significantly, the acetabulum reamer publication does not teach a disposable spherical hollow surgical reamer tool that is attached to a drive shaft with coincident centerlines.
There remains a need in the art for a modular easy-to-assemble spherical hollow reamer for medical applications having a disposable spherical hollow cutter. Also needed in the art is a disposable spherical hollow cutter assembly of the type described, which can be attached concentric to a reusable shaft portion that provides means for reaming of an acetabular bone cavity in bones without any wobbly movement. Further needed in the art is a cutter assembly having means for collecting bone debris and keeping the collected debris displaced from the cutting portion, so that heat generated at the bone cutting surface is minimized. Still further needed in the art is a spherical hollow reamer assembly wherein, after one use of the spherical hollow reamer, a new spherical hollow cutter with sharp fresh cutting edges can be utilized and the old hollow cutter can be discarded.